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Why PharmaSys?
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Speed your
Process Development & Process Validation Program
PharmaSys
personnel are experienced in process
development, scale up, process
optimization and process
validation. As a full service
compliance firm, PharmaSys can
provide customers with strategies to
ensure manufacturing processes are
robust and the defined critical
parameters are based on data driven
scientific techniques such as Design
of Experiments (DOE), Design for
Manufacturing (DFM), and Quality by
Design (QbD). PharmaSys personnel
understand the Chemistry,
Manufacturing and Control (CMC)
requirements for regulatory
submissions and utilize that
knowledge to develop the strategies
to produce the required data.
As an extension to our process
development service, PharmaSys can
provide the expertise to develop
your process validation strategy and
manage execution of the validation
process as required. In addition,
PharmaSys can utilize our personnel
expertise to help troubleshoot
problem areas in your manufacturing
process. We can perform and manage
Failure Mode Effect Analysis (FEMA)
events, risk assessments, root cause
analysis, and data mining.
Whether you are scaling up a new
manufacturing process, expanding
your process into additional
facilities or making changes to an
existing process, our engineers have
the technical skills, compliance
knowledge, validation experience and
leadership to get your process
validated with the least amount of
time and expense to you.
When it comes to developing and validating
your processes, PharmaSys exceeds your
expectations!
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Areas of Expertise
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